MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PROTECTA XT CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number D314TRG

Device Problems Device Alarm System (1012); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the cardiac resynchronization therapy defibrillator (crt-d) did not trigger elective replacement indicator (eri) and would not alert at interrogation or sound an alarm.The crt-d was explanted and replaced.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTECTA XT CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7808984
• MDR Text Key: 117992902
• Report Number: 3004209178-2018-18966
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00613994677884
• UDI-Public: 00613994677884
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/28/2014
• Device Model Number: D314TRG
• Device Catalogue Number: D314TRG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 694758 LEAD, 429678 LEAD, 5076-45 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR